Pemetrexed in Maintenance in Patients With Impaired Renal Function, 2 Dose Calculation Strategies

NCT03607149 | Completed Phase 4

• 1 other identifier: 2016-002552-24
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs. The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

Conditions

Non-small Cell Lung Cancer

Keywords

Pemetrexed; Non-small cell lung cancer; Clearance of creatine

Outcome Measures

Primary Outcomes (1)

• Median time until treatment is stopped due to renal function ≤ 45mL / min

  From date of randomization until the date of treatment is stopped

  1 year

Secondary Outcomes (1)

• Progression-free survival

  up to 100 weeks

Study Arms (2)

STANDARD ARM

ACTIVE COMPARATOR

Calculation of the dose of pemetrexed as a function of body surface area

Drug: Pemetrexed

EXPERIMENTAL ARM

EXPERIMENTAL

Calculation of the pemetrexed dose as a function of the Clearance of creatine (CrCLCG)

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

standard arm : calculating the dose of pemetrexed according to body surface area experimental arm: calculation of the dose of pemetrexed as a function of creatinine clearance (CrCLCG)

EXPERIMENTAL ARM; STANDARD ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Patient with non-small cell lung cancer predominantly non-epidermoid histologically documented
• Patient who is scheduled to initiate treatment or undergoing maintenance therapy by pemetrexed
• Neutrophils\> 1500 / mm3; Chips\> 100,000 / mm3
• Informed, dated and signed consent For patients of childbearing age, effective contraceptive method
• Creatinine clearance according to the Cockcroft-Gault formula between 70 and 45 mL / min
• PS = 0 or 1

You may not qualify if:

• Patient with a contraindication to pemetrexed therapy
• Patient with symptomatic brain metastases
• Pregnant or nursing women
• Patient under guardianship or curatorship or subject to a system of protection for persons of full age
• Patient not affiliated to a social security scheme (beneficiary or beneficiary)

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (3)

CH William Morey

Chalon-sur-Saône, 71100, France

Location

Centre Georges Francois Leclerc

Dijon, 21079, France

Location

Centre Universitaire Hospitalier de Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: July 31, 2018
• Study Start: April 6, 2017
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

FR (3)